Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Avelumab

Immunomodulating Agents

Antimetabolites

Antineoplastic Agents, Immunological

CHEMORADIOTHERAPY PLUS AVELUMAB:

CAPECITABINE 825 mg/sqm/bid p.o. 5 days/week EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 fractions over 5.5 weeks AVELUMAB 10 mg/Kg ev over 1 hour every 2 weeks at days 1, 14, 28, 42, 56, 70

Eligible patients will receive:

CHEMORADIOTHERAPY PLUS AVELUMAB:

* CAPECITABINE 825 mg/sqm/bid p.o. 5 days/week
* EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 fractions over 5.5 weeks
* AVELUMAB 10 mg/Kg ev over 1 hour every 2 weeks at days 1, 14, 28, 42, 56, 70

Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion.

Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion.

EXTERNAL---BEAM IRRADIATION 50.4 GY

Preoperative CTRT is considered the standard of care in the management of LARC. Preoperative CTRT approach results in significant tumor downstaging and local control with a complete pathological response rate of about 15% even if additional therapeutic strategies should be explored to improve outcomes, expecially for T4 cancers.

Immunotherapy with PD-1/PD-L1 immunocheckpoint blockade (ICB), turned out a breakthrough in cancer treatment among different tumor types, including CRC. An ICB strategy could lead up to a 40% of response in metastatic CRC with deficient mismatch repair (MMR) status. Unfortunately, the activity of ICBs in MMR proficient mCRC is extremely low but it might be improved using immunomodulatory strategies as demonstrated by Bendell et al.

In this context, the role of RT in revert the tolerance to a low neoantigen-burden (such as in MMR proficient CRCs) by the induction of antigen release from the tumour and activation of dendritic cells leading to a CD8+ T lymphocyte-mediated anticancer immune response has been widely elucidated. Moreover, antineoplastic agents can be exploited to target other crucial cellular effectors of immunosuppressive tumor microenvironment (i.e. regulatory T cells and myeloid-derived suppressor cells).

In line with these evidences, Hecht et al. have recently reported that in rectal cancer patients, neoadjuvant CTRT increases PD-L1 expression in tumor cells, strongly suggesting a neoadjuvant combinatory strategy with RT and PD-1/PD-L1 pathway blockade. The integration of immunotherapy in the neoadjuvant setting (instead of adjuvant one) for the management of LARC is also supported by preclinical findings showing that in metastatic breast cancer mice models, neoadjuvant immunotherapy is superior in inducing long-term survivors, compared with adjuvant strategy with a greater magnitude of tumor-specific T cell expansion in neoadjuvant treated mice and a better anti-tumor T cell-mediated immune response.

On the basis of such considerations, there is a strong biological and clinical rationale for testing the addition of avelumab, an anti-PD-L1 moab, to capecitabine-based CTRT in patients with technically resectable, LARC. The aim of this strategy is to lead to significant improvements of pCR and, ultimately, patients' survival.

Immunotherapy In Locally Advanced Rectal Cancer

Phase II Study Of Preoperative Chemoradiotherapy Plus Avelumab In Patients With Locally Advanced Rectal Cancer

pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells yT0N0

is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing R0 resection of primary tumour

is defined as reduction of at least one level in T or N staging between the baseline MRI and histopathological staging, without evidence of upstaging or disease progression.

is defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis.

is defined as the percentage of patients undergoing sphincter-sparing surgery.

Gruppo Oncologico del Nord-Ovest

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Agents

Herbal and Botanical

Laxatives

Cathartics

Cola

Patients receiving 1LPEG who had a colonoscopy in the morning were advised to follow a day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, they prepared the Dose 1 sachet in 500 mL of water and consumed it over a period of 30 minutes, followed by 500 mL of clear liquids. The second dose was then taken at 11:00 pm by mixing the two Dose 2 sachets in a single glass of 500 mL of water and consuming them over 30 minutes, followed by 500 mL of clear liquids. If the colonoscopy was scheduled for the afternoon, the same dosing instructions were given, but the first dose was taken at 7:00 am on the day of the procedure, and the second dose began at 10:00 am.

Patients receiving 2LPEG who had a colonoscopy in the morning were asked to follow a similar day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, the first 1L dose was consumed over a 1-hour period, followed by the second dose at 11:00 pm. For 2LPEG patients with procedures in the afternoon, they took Dose 1 at 7:00 am and Dose 2 at 10:00 am. Any patient receiving 2LPEG was also told to consume 1L of clear liquids during the preparation procedure.

PLENVU

MoviPrep

Compare the quality of bowel preparation between two groups of patients, who will undergo two different preparations: 1. Moviprep + diet; 2. Plenvu + diet

The quality of bowel preparation is essential for the success of a colonoscopy, reducing colonoscopy duration, and increasing the rate of cecal intubation and of polyp detection. There are several types of preparations available on the market and, irrespective of the choice, the split-dose regimen should be followed. A reduced volume preparation makes the process easier and more tolerable, increasing adhesion. Regarding the diet to be applied before the examination, there are no advantages to a liquid diet compared to a low fiber diet, and there is no evidence on the duration of the diet. In addition, a restrictive diet has an impact on satisfaction and also on adherence to treatment.

Comparison of Two Preparations for the Study of the Colon Through Colonoscopy

Comparative, Prospective and Randomized Study of Two Preparations for the Study of the Colon Through Colonoscopy

The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of \>6 with no individual segment scoring \<2.

The level of patient satisfaction with the 2 bowel preparation regimens was also assessed through a comparative analysis of the patient satisfaction questionnaire

Hospital da Senhora da Oliveira

Principal Investigator

Heart and Blood Diseases

Heart Failure

Noncommunicable Diseases

Disease Attributes

The intervention group will participate in a 42-day nurse-assisted intervention "eHealth@ Hospital-2-Home". The intervention includes monitoring of vital signs, self-reports of symptoms, health and well-being, access to information about illness and health resources , and communication between the patients and a hospital-based Nurse Navigator.

The control group will receive care as usual

At hospital discharge, the intervention group will receive a wireless, portable personal computer system (i.e., IPAD) that includes the eHealth application MyDignio supplied by a certified m-Health company. MyDignio app is linked to monitoring devices by Bluetooth for each patient to daily and weekly measure clinical measures such as blood pressure, pulse, temperature, and weight, and self-reported symptoms and well-being, and daily report clinical measurements to the Nurse Navigators employed in the two hospitals. The patients will receive training from the nurses on how to log on and use the MyDignio app and the monitoring devices. Telephone contact details including information about how to access technical support will be provided to each study participant shortly following discharge.

eHealth@Hospital-2-Home

Anne Marie L Husebø, PhD

Svein Scheie, MD, PhD

Marianne Storm, PhD

Ingvild M Morken, PhD

Anne Marie Husebø, PhD

A randomized controlled trial with non-communicable disease patients from two medical hospitals in Norway will be recruited prior to hospital discharge. The intervention group will participate in a 42-day nurse-assisted eHealth intervention "eHealth@ Hospital-2-Home". The intervention includes monitoring the patient's vital signs, self-reports of symptoms, health and well-being, communication between the patients and a Nurse Navigator in the hospital, and access to information about illness and health resources.

Heart failure (HF) and colon-rectal cancer (CRC) are two non-communicable diseases (NCDs) prone to a high rate of hospital admissions and re-admissions, and complex health care needs. For many patients with HF and CRC, self-management following hospitalization can be a challenge, and they may leave the hospital unprepared for self-managing their disease at home. The randomized controlled trial with NCD patients from two medical hospitals in Norway. Patients will be recruited before hospital discharge. The intervention group will participate in a 42-day nurse-assisted intervention ""eHealth@ Hospital-2-Home"". The intervention includes monitoring of patients' vital signs, self-reports of symptoms, health and well-being, communication between the patients and a Nurse Navigator in the hospital, and access to information about illness and health resources. The control group will receive care as usual. Data collection will take place before the intervention (baseline), at the end of the intervention (post-1), and 6 months after baseline (post-2). Data will be according to intention to treat principles. Qualitative data will be analyzed using thematic analysis.

A randomized controlled trial with intervention and control group

Randomization will be blinded for the researchers performing the data analysis.

Nurse-assisted Intervention "eHealth@ Hospital -2-home"

Project Title: Nurse Assisted eHealth Service From Hospital to Home: Ameliorating Burden of Treatment Among Patients With Non-Communicable Diseases

Change in medication adherence will be measures using the Medication Adherence Reasons Scale-5 (MARS -5) containing 5 items.

Patient satisfaction with using the technology will be measured by the Post-Study System Usability Questionnaire. Values: 1-7. Higher score mean worse outcome.

Change in the patient's confidence in self-management of heart failure or colon-rectal cancer disease between baseline and post-1 and 2 will be measured by the 6 items questionnaire Self-Efficacy for Managing Chronic Disease". Values: 1-10. A higher score mean a better outcome.

Change in heart failure patients' self-care behavior between baseline and post-1 and 2 will be measured by use of the European Heart Failure Self-care Behavior Scale. Value: 1-5. Higher score mean worse outcome.

Change in the patient's experience with treatment and self-management of heart failure and colon-rectal cancer between baseline and post-1 and 2 will be measured by the questionnaire "Patient Experience with Treatment and Self-management" with four dimensions of Medical information (Values:1-6); Monitoring health (Values: 1-6); Medications (Values 1- 5); Medical appointments (Values: 1-5). Higher scores means a worse outcome.

Change in the patient's Health Related Quality of Life between baseline and post 1 and 2 will be measured with the European Quality of life 5 Dimensions -5 Levels questionnaire. Values: 1-5, were higher scores mean worse outcome, and on a visual analog scale from 0-100, were higher scores mean better outcome.

Change in perceived support between baseline and post-1 and 2 will be measured using 12 items on constructive support. Values: 1-5-point. Higher score mean worse outcome.

Change in the patient's experience of shared decision-making between baseline and post-1 and 2 will be measured using the 3 items questionnaire "CollaboRATE" Value: 0-10. Higher score mean better outcome.

Change in health care utilization between baseline and post-1 and 2 will be measured using patients' self-reports of number of visits to the primary healthcare service (i.e., General Practitioner, municipal emergency department) and/or the specialist healthcare service (i.e., outpatient clinic). Fewer visits mean better outcome.

Days alive and out of hospital will be measured by patient's self-report against data from hospital records, and calculated by subtracting number of days spent away from home due to heart failure or colon-rectal cancer related hospitalization from the day of the first reporting in the patient application and the six months following (post 2).

Numbers of 30-days readmission for Heart failure or Colon-rectal cancer related incidents will be collected from the electronic health care record system in the hospital.

Numbers of 30-days readmission for heart failure or colon-rectal cancer related incidents will be collected from the electronic health care record system in the hospital.

Numbers of 12-months readmission for heart failure or colon-rectal cancer related incidents will be collected from the electronic health care record system in the hospital.

Helse Stavanger HF

St. Olavs Hospital

University of Stavanger

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Lung Neoplasms

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Stomach Cancer

Vaccines

tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times

DC vaccine subcutaneous administration

Qiu Li

Qiu Li, PhD

The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.

Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

Personalized DC Vaccine for Postoperative Cancer

Adjuvant Treatment in Cancer Patients With Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial

Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first

Defined by the time between the date of randomization and the date of death

Defined by treatment-related adverse events as assessed by CTCAE v4.0

Sichuan University

Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Syndrome

Colonic Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Colonic Diseases

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Familial Colorectal Cancer

Enrolled participants will watch three educational videos in Spanish pertaining to: (1) Colorectal Cancer (CRC) symptoms; (2) CRC risk factors and (3) CRC screening, treatment, and Cancer Clinical Trials (CCT).

Enrolled participants will watch three educational videos on Colorectal Cancer (CRC) in Spanish. Knowledge on CRC symptoms, risk factors, screening and treatment will be assessed before and immediately after the educational video and at 30 +/- 7 days. In addition, the association between increase in CRC knowledge and willingness to participate in Cancer Clinical Trials (CCT) will be explored.

Colorectal Cancer Educational Videos in Spanish

José G. Guillem, MD, MPH, MBA

Dimitrios Varvoglis, MD

Jose G Guillem, MD, MPH, MBA

The study aims to recruit 60 Spanish speaking individuals who identify as Latinos, are older than 18 years old and attend the Saint Thomas More (STM) Church in Chapel Hill. Study participants will be asked to attend an educational session at STM Church during which their baseline knowledge on colorectal cancer (CRC) and willingness to participate in cancer clinical trials (CCT) will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational videos on CRC in Spanish. After watching the videos, CRC knowledge and willingness to participate in CCTs will be reassessed. Thirty +/- 7 days after participation in the educational session, participants will be invited back at STM Church in order to complete a follow-up questionnaire assessing CRC knowledge, willingness to participate in CCTs and perceived barriers preventing Latinos from participating in CCTs. Twenty of the 60 recruited participants will be asked to participate in a qualitative one-on-one interview aimed at identifying barriers preventing Latinos from participating in CCTs.

It should be noted that cancer is the leading cause of death in the United States (US) Latino community, with CRC accounting for 10% of this overall mortality. Despite this, Latinos suffer from disparities in access to care, cancer screening, treatment, and representation in CCTs. In fact, although Latino individuals are among the largest and fastest growing communities of color in the US, currently comprising 18.7%, their representation in CCTs remains low. This is of concern because: 1) advances arising from trials with limited Latino representation may not be applicable to the Latino population, and 2) decreased Latino participation in CCTs may delay Latino access to novel therapies in a timely fashion. The investigators conducting this study believe that low cancer-specific health knowledge may be impacting Latino representation and willingness to participate in CCTs and can be addressed through culturally and linguistically appropriate community-based educational interventions. Latino CCT underrepresentation is a multifaceted phenomenon and bidirectional barriers at the physician-, healthcare system-, and patient-level are significant contributors. Therefore, understanding the multiple driving forces and barriers is essential to identifying potential targets for improvement.

This pilot project aims to address the Clinical and Translational Science (CTS) roadblock of underrepresentation of Latinos in cancer clinical trials (CCTs) through a community-based, culturally, and linguistically appropriate educational intervention aimed at increasing health knowledge on a specific cancer. Colorectal cancer (CRC) will be the "use case" and the church will be the venue for Latino recruitment. This project will lead to the identification of novel Latino-perceived barriers to CCT enrollment, which will be applicable in other fields of medicine aiming to increase Latino CCT enrollment. The investigators believe that one barrier to recruitment for CCTs is low health education, specifically regarding cancers affecting the community, such as CRC, a commonly diagnosed cancer in the US Latino population. Therefore, the hypothesis that an increase in health knowledge in Latinos on a specific cancer mediates a change in their willingness to participate in CCTs will be tested. To do this, three educational CRC videos in Spanish will be created. The first video will review CRC symptoms, the second video will review CRC risk factors while the third video will provide information on CRC screening, treatment and CCTs. In addition, a translated, non-validated questionnaire based on 3 sub-scales from 2 CRC knowledge questionnaires previously validated in English will be developed and pilot tested. Therefore, the Specific Aims of this Pilot Project are to:

1. Identify novel Latino-perceived barriers to participation in CCTs.
2. Assess the association between an educational video and CRC knowledge.
3. Explore the potential relationship between an increase in health knowledge of a specific cancer via an educational video in Spanish and willingness to participate in CCTs.
4. Demonstrate that engagement with Latino communities via the church setting is a viable option for the recruitment and retention of Latinos.
5. Translate into Spanish and pilot test 3 health knowledge sub-scales as a preliminary step in the creation and validation of a novel Spanish CRC knowledge questionnaire.

To achieve these aims, recruit 60 Latino, Spanish speaking attendees of the Saint Thomas More (STM) Church in Chapel Hill will be recruited. The study will consist of three Study Days:

1. Study Day 1: Enrolled participants will be asked to attend an educational session at STM Church. During the educational session their baseline knowledge on CRC and their baseline willingness to participate in CCTs will be assessed through a questionnaire in Spanish. Following this, participants will watch three educational CRC videos in Spanish and then their CRC knowledge as well as their willingness to participate in CCTs will be reassessed.
2. Study Day 2: Thirty +/- 7 days after the educational session, participants will be asked to return to STM Church in order to complete a follow-up questionnaire in Spanish. The questionnaire will assess their level of retainment of CRC knowledge, their willingness to participate in CCTs as well as assess in an open-ended fashion their perceived barriers to CCT participation.
3. Study Day 3: Twenty of the 60 enrolled participants will be asked to participate in a qualitative one-on-one interview aimed at identifying Latino perceived barriers to CCT participation.

PeLear CCC: Proyecto Latino Contra Cancer Colorectal

A Colorectal Cancer Educational Intervention in the Latino Community Assessing the Feasibility of Recruitment & Retention Via a Church-Based Approach: Identification of Novel Barriers to Cancer Clinical Trial Enrollment

Qualitative, semi-structured, one-on-one interviews will be performed in Spanish. The interviews will be recorded and transcribed. The ATLAS.ti software will be used for the transcript analysis. The top 2 conceptual themes within each section of the interview-attitudes regarding general clinical trials, attitudes regarding cancer clinical trials, and perceptions of the Hispanic/Latino community-and the top 3 higher-level, holistic themes across the sections will be reported in terms of percentage of participants.

Use of appropriate statistical measures to compare total number of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) symptoms will be assessed using the "Knowledge of Warning Signs" questions from the "Bowel Cancer Awareness Measure". Potential answers include "Yes", "No" and "Don't Know". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms.

Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge pertaining to Colorectal Cancer (CRC) risk factors will be assessed using the "Knowledge of Risk Factors" questions from the "Bowel Cancer Awareness Measure". This scale is measured using a Likert 1-5 scale with "1" corresponding to "Strongly Disagree" and "5" corresponding to "Strongly Agree". The overall score will range from 11 to 55 and it is anticipated that the average scores will increase after the intervention. Higher scores imply greater knowledge of risk factors.

Use of appropriate statistical measures to compare mean proportion of correct responses across three time points (at baseline, post-video and 30+/- 7 days follow-up) accounting for multiple observations within subjects. Knowledge of Colorectal Cancer (CRC) screening and general facts will be assessed using nine questions from the "Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI)". The overall score will range from 0 to 9 and it is anticipated that average scores will increase after the intervention. Higher scores imply greater knowledge of symptoms.

Appropriate statistical measures on the paired responses of participants will be used to test the association between watching the video and willingness to participate in CCTs. The mediating effect of health knowledge levels (M) on the relationship between educational video (X) and willingness to participate in CCTs (Y) will be explored. In a structural equation model with a series of mixed-effects generalized linear models, Y will be predicted by both X and M, combining the estimated relationship of M and Y. The mediated indirect effect (from X to Y, through M) will then be estimated and tested using the bootstrapping method with 1,000 replications, and the proportion of the effect being mediated will be reported as the effect size.

North Carolina Translational and Clinical Sciences Institute

University of North Carolina, Chapel Hill

Anti-Infective Agents

Bevacizumab

Trifluridine

Angiogenesis Inhibitors

Growth Inhibitors

Antiviral Agents

Patients with mCRC who started with regorafenib first, followed by TAS+/-Bev (Bevacizumab) without other therapies in between.

Patients with mCRC who started with TAS+/-Bev first, followed by regorafenib, without other therapies in between.

Patients with mCRC who received combo use of TAS+BEV.

Regorafenib (BAY73-4506, Stivarga®)

TAS-102 (trifluridine and tipiracil, Lonsurf®)

This is an observational study using data that has been collected from participants who received their usual treatments.

Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus) that has spread to other parts of the body.

Regorafenib is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. The combination of anti-cancer drugs trifluridine and tipiracil is called TAS-102. It prevents cancer cells from growing and multiplying.

Both regorafenib and TAS-102 are approved treatments for metastatic colorectal cancer and are available for doctors to prescribe to people with mCRC after previous lines of treatment have been unsuccessful.

Regorafenib and TAS-102 work in different ways and impact people differently. People might receive one of these drugs first and followed by the other. The best sequence for taking these drugs is still unclear.

Researchers have also found that TAS-102, when taken with another anti-cancer drug called bevacizumab, helps people live longer than when taken alone.

To better understand the impact of the sequence of taking regorafenib and TAS-102 (with or without bevacizumab), more knowledge is needed about how these work together in people with mCRC in real world settings.

The main purpose of this study is to learn more about the characteristics and impact of treatment in people with mCRC who received regorafenib and TAS-102 (with or without bevacizumab) one after the other. This information will be grouped based on their treatment sequence and age group (less or more than 65 years old).

In addition, the researchers want to learn about :

* how long participants were treated with regorafenib and TAS-102 taken one after the other in a sequential order,
* any treatment for mCRC that the participants received after the sequential treatment,
* any treatment received for a condition in which the bone marrow cannot make up enough blood cells (a common side effect of cancer treatment), during the sequential treatment,
* if and how often white blood cells that fight infection decreased during the sequential treatment,
* the number of hospital or testing facility visits that participants had during the sequential treatment, and
* how long did participants live (also called overall survival).

The participants in this study had already received regorafenib and TS-102 (with or without bevacizumab) as part of their regular care from their doctors.

The data will come from the participants' information stored in an electronic health records database called Flatiron mCRC EDM. Data collected will be from January 2015 to December 2022.

Researchers will only look at the health information from adults in the United States of America.

In this study, only available data from routine care is collected. No visits or tests will be required as part of this study.

An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions

(STAR-T) Sequential TreAtment With Regorafenib and Trifluridine/Tipiracil (TAS-102, With or Without Bevacizumab) in Refractory Metastatic Colorectal Cancer: Real-world Outcomes in Community Clinical Practice in the USA

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Demographic includes age, gender, race and ethnicity, insurance.

Clinical characteristics includes number and type of prior therapies patient received for mCRC, stage at initial diagnosis, performance status, histology, time since metastatic diagnosis, Line of Treatment (LOT) of index treatment

Biomarker B-Raf Proto-Oncogene (BRAF) and Mismatch Repair / Microsatellite instability (MMR/MSI) will be explored depending on data availability.

Myelosuppression related medical interventions \[e.g., use of Granulocyte colony stimulating factors (G-CSF)\]

Health care resource utilizations includes office/hospital visit and lab visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy In Locally Advanced Rectal Cancer	NCT03854799	Colon Rectal Ca...	Avelumab Capecitabine EXTERNAL---BEAM...	18 Years -	Gruppo Oncologico del Nord-Ovest
Comparison of Two Preparations for the Study of the Colon Through Colonoscopy	NCT04497935	Colon Cancer Colon Polyp Colon Adenoma Colon Rectal Ca...	PLENVU MoviPrep	18 Years -	Hospital da Senhora da Oliveira
Nurse-assisted Intervention "eHealth@ Hospital -2-home"	NCT05750953	Non Communicabl... Heart Failure Colon Rectal Ca...	eHealth@Hospita...	18 Years -	University of Stavanger
Personalized DC Vaccine for Postoperative Cancer	NCT04147078	Gastric Cancer Hepatocellular ... Non-Small-Cell ... Colon Rectal Ca...	DC vaccine subc...	18 Years - 100 Years	Sichuan University
Immunotherapy In Locally Advanced Rectal Cancer	NCT03854799	Colon Rectal Ca...	Avelumab Capecitabine EXTERNAL---BEAM...	18 Years -	Gruppo Oncologico del Nord-Ovest
PeLear CCC: Proyecto Latino Contra Cancer Colorectal	NCT06426927	Colorectal Canc... Rectal Cancer Colon Cancer Colon Rectal Ca... Rectal Neoplasm... Colon Adenocarc... Hereditary Nonp...	Colorectal Canc...	18 Years -	University of North Carolina, Chapel Hill
Comparison of Two Preparations for the Study of the Colon Through Colonoscopy	NCT04497935	Colon Cancer Colon Polyp Colon Adenoma Colon Rectal Ca...	PLENVU MoviPrep	18 Years -	Hospital da Senhora da Oliveira
An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions	NCT05839951	Metastatic Colo...	Regorafenib (BA... TAS-102 (triflu... Bevacizumab	18 Years -	Bayer
Comparison of Two Preparations for the Study of the Colon Through Colonoscopy	NCT04497935	Colon Cancer Colon Polyp Colon Adenoma Colon Rectal Ca...	PLENVU MoviPrep	18 Years -	Hospital da Senhora da Oliveira

Spots Global Cancer Trial Database for colon rectal cancer